Abstract
Purpose
The purpose of this study is to assess the impact of palifermin on oral mucositis (OM) and its sequelae in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) who were conditioned with fractionated total body irradiation (FTBI) and etoposide.
Methods
This retrospective chart review study compared the effect of palifermin on the development of OM in patients who received this agent during an allo-HSCT (n = 99) to those who did not (n = 30). The primary end points were severity and duration of OM. Secondary end points included requirements for opioids, total parenteral nutrition (TPN), and intensive oral care; incidence of infection; length of hospital stay; and overall survival.
Results
There was no significant difference in the incidence of all grades of OM, but incidence of severe OM was decreased in palifermin-exposed patients (34 vs 80 %, p < 0.0001). In patients who developed OM (all grades), the median duration of OM was shorter in palifermin-exposed patients (13 vs 18 days, p = 0.0001); there was no difference in the median duration of severe OM. Patients who received palifermin used less opioids and required a shorter duration of intensive oral care. There was no difference in duration of TPN, incidence of infection, length of hospital stay, and overall survival.
Conclusions
Our findings demonstrated a significant benefit with the use of palifermin for allo-HSCT recipients who were conditioned with FTBI and etoposide. Palifermin can potentially improve quality of life for this patient population and reduce complications and resources used during the transplant process. A randomized clinical trial is required to confirm these results.
Similar content being viewed by others
References
Hensley ML, Hagerty KL, Kewalramani T et al (2008) American Society of Clinical Oncology 2008 Clinical Practice Guideline Update: use of Chemotherapy and Radiation Therapy Protectants. J Clin Oncol 27:127–145
Epstein JB, Thariat J, Bensadoun RJ et al (2012) Oral complications of cancer and cancer therapy: from cancer treatment to survivorship. Cancer J Clin 62(6):400–422
Woo SB, Sonis ST, Monopoli MM et al (1993) A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients. Cancer 72:1612–1617
Elad S, Raber-Durlacher JE, Brennan MT et al (2014) Basic oral care for hematology-oncology patients and hematopoietic stem cell transplantation recipients: a position paper from the joint task force of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) and the European Society for Blood and Marrow Transplantation (EMBT). Support Care Cancer. doi:10.1007/s00520-014-2378-x
Lalla RV, Bowen J, Barasch A et al (2014) MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer 120(10):1453–1461
Raber-Durlacher JE, Laheij AM, Epstein JB et al (2013) Periodontal status and bacteremia with oral viridans streptococci and coagulase negative staphylococci in allogeneic hematopoietic stem cell transplantation recipients: a prospective observational study. Support Care Cancer 21(6):1621–1627
Sonis ST, Elting LS, Keefe D et al (2004) Perspectives on cancer therapy-induced mucosal injury. Cancer 100(9 Suppl):1995–2025
Sonis ST, Oster G, Fuchs H et al (2001) Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol 19:2201–2205
Rubin JS, Bottaro DP, Chedid M et al (1995) Keratinocyte growth factor. Cell Biol Int 19(5):399–411
Raber-Durlacher JE, von Bultzingslowen I, Logan RM et al (2013) Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients. Support Care Cancer 21(1):343–355
Farrell CL, Bready JV, Rex KL et al (1998) Keratinocyte growth factor protects mice from chemotherapy and radiation-induced gastrointestinal injury and mortality. Cancer Res 58(5):933–939
Blazar BR, Weisdorf DJ, DeFor T et al (2006) Phase 1/2 randomized, placebo-control trial of palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Blood 108(9):3216–3221
Spielberger R, Stiff P, Bensinger W et al (2004) Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 351:2590–2598
Kepivance [package insert] (2011). Stockholm, Sweden: Swedish Orphan Biovitrum AB
Levine JE, Blazar BR, DeFor T (2008) Long-Term follow-up of a Phase I/II Randomized, Placebo-Controlled Trial of Palifermin to Prevent Graft-versus-Host Disease (GVHD) after Related Donor Allogeneic Hematopoietic Cell Transplantation (HCT). Am Soc Blood Marrow Transplant 14:1017–1021
Horsley P, Bauer JD, Mazkowiack R et al (2007) Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation. Support Care Cancer 15:105–109
Keefe D, Lees J, Horvath N (2006) Palifermin for oral mucositis in the high-dose chemotherapy and stem cell transplant setting: the Royal Adelaide Hospital Cancer Centre experience. Support Care Cancer 14:580–582
Langner S, Staber PB, Schub N et al (2008) Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant 42:275–279
Nasilowska-Adamska B, Rzepecki P, Manko J et al (2007) The influence of palifermin (Kepivance) on oral mucositis and acute graft versus host disease in patients with hematological diseases undergoing hematopoietic stem cell transplant. Bone Marrow Transplant 40:983–988
Rzepecki P, Sarosiek T, Barzal J et al (2007) Palifermin for prevention of oral mucositis after haematopoietic stem cell transplantation-single centre experience. J Buon 12(4):477–482
Goldberg JD, Zheng J, Castro-Malaspina H et al (2012) Palifermin is efficacious in recipients of TBI-based but not chemotherapy-based allogeneic hematopoietic stem cell transplants. Bone Marrow Transplant 48(1):99–104
Stiff P, Spielberger R (2013) Palifermin for prevention of oral mucositis has no negative effect on long-term outcome in patients with hematological malignancies undergoing HSCT – long-term follow-up To 15 Years. Blood;122(21)
Cutler C, Li S, Kim HT et al (2005) Mucositis after Allogeneic Hematopoeitic Stem Cell Transplantation: A Cohort Study of Methotrexate- and Non-Methotrexate-Containing Graft-versus-Host Disease Prophylaxis Regimens. Biol Blood Marrow Transplant 11:383–388
Acknowledgments
The authors would like to thank Tanya Paris and Lucy Hallijian for assistance in data collection.
Conflict of interest
This research was not sponsored by any outside organization; thus, the authors do not have a financial relationship with such organization. The authors have full control of all primary data and agree to allow the Journal to review the data if requested.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Nguyen, D.T., Shayani, S., Palmer, J. et al. Palifermin for prevention of oral mucositis in allogeneic hematopoietic stem cell transplantation: a single-institution retrospective evaluation. Support Care Cancer 23, 3141–3147 (2015). https://doi.org/10.1007/s00520-015-2688-7
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-015-2688-7